Determinants of the Effectiveness of Robot-assisted Hand Movement Training

N/AActive Not RecruitingNCT04818073

University of California, Irvine60 enrolled

Overview

The investigators would like to investigate the effectiveness of somatosensory training for robot-assisted hand motor rehabilitation after stroke.

From previous studies, the investigators learned that stroke survivors with impaired finger proprioception did not achieve as large a functional benefit from robotic finger training. For this study, the investigators would like to determine if and the extent of finger proprioception can be improved through targeted robotic proprioceptive training combined with robotic finger movement training. The investigators would also include imagining studies via Electroencephalogram (EEG) and other baseline predictors to provide insight to determine who responds best to proprioceptive training.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Stroke, Ischemic Cerebrovascular Accident (CVA)

Interventions

New FINGERDEVICE

New FINGER exoskeleton is a robotic device that can provide assistance and resistance to thumb and finger movement

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18 to 85 years * Suffered from a single ischemic stroke (radiologically confirmed) at least 6-months prior to enrollment * An ability to score at least 3 blocks on the Box and Block Test Exclusion Criteria: * A substantial decrease in alertness, language reception or attention * Pregnant or lactating * Advanced liver, kidney, cardiac or pulmonary disease * Plan to alter any current participation in other rehabilitation therapy in the time period of the study * A terminal medical diagnosis consistent with survival \< 1 year * Coexistent major neurological disease * Coexistent major psychiatric disease * A history of significant alcohol or drug abuse in the prior 3 years * Current enrollment in another study related to stroke or stroke recovery * Any other medical contraindication to participation in this study evaluated by our team physician.

Locations (1)

University of California Irvine

Irvine, California, United States

Outcomes

Primary Outcomes

Box and Blocks Test

We compare the change of Box and Block Test scores from baseline evaluation to 1-month post intervention. Participants are instructed to move as many blocks as possible, one at a time, from one compartment in a box to a second compartment over a divider for a period of 60 seconds; each block that is moved is counted, and multiple blocks moved at the same time are counted as a single block. The higher scores indicate a better outcome.

Time frame: From baseline to 1-month post intervention

Secondary Outcomes

Fugl-Meyer Motor Assessment of the Upper Extremity

We will measure the change of the Fugl-Meyer Motor Assessment scores from the baseline evaluation to 1-month post intervention. Fugl-Meyer is a 66-point scale measuring the movement pattern of upper extremities. The higher scores indicate a better outcome.

Time frame: From baseline to 1-month post intervention

Motor Activity Log

We will measure the change of the Motor Activity Log (MAL) mean scores from the baseline evaluation to 1-month post intervention. The Motor Activity Log is a 30 questionnaire that collect subjective measure of an individual's real life functional upper limb performance. The higher scores indicate a better outcome.

Time frame: From baseline to 1-month post intervention

Changes in finger proprioception measured using the Crisscross Assessment.

We will measure the change in finger proprioception scores from the baseline evaluation to 1-month post intervention. Finger proprioception is measured by using the FINGER Crisscross Assessment which we slowly move the index and middle fingers with the FINGER robot past each other without any visual input. We then ask study participants to press a key when they feel the fingers are overlapped. Finger proprioception is measured by the error which will be quantified as the mean magnitude of finger separation error at the metacarpal joint when the key is pressed. The lower scores indicate a better outcome.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.